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18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Tumor

Treatments

Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT01485679
BRD/10/06-P

Details and patient eligibility

About

The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results will be compared to those obtained by the pathological analysis of the removed piece of pancreas.

Full description

Before surgery is undertaken, a 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography (18-FDG TEP-CT ) will be performed. The primary outcome of this study is to compare results of the TEP-CT with those obtained by the pathological analysis of the removed piece of pancreas.

Enrollment

126 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults with age equal or above 18
  • Patients diagnosed with intraductal papillary mucinous tumor with surgical indication and for whom it will be possible to have the pathological analysis of the removed piece of pancreas.
  • if woman being of childbearing potential, woman taking contraceptive measures
  • Patient able to understand benefits and risks of protocol
  • Subject affiliated to French health insurance (Social Security)
  • Informed consent form signed

Exclusion criteria

  • Patients not fulfilling inclusion criteria
  • Pancreatic surgery or radiotherapy in the pancreatic zone within 4 the months preceding the TEP-CT
  • Chemotherapy within 2 the months preceding the TEP-CT
  • Acute pancreatitis within 2 the months preceding the TEP-CT
  • Pregnant women or breast-feeding women refusing to temporary stop it
  • Diabetes not equilibrated (checked by glycemia and glycosylated hemoglobin (HbA1c) at inclusion) or Fasting blood glucose below 7mmol/L (126 g/L before the TEP)
  • Patients with claustrophobia
  • Patients not accepted under the anesthesia point of view

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

126 participants in 1 patient group

positrons emission tomography
Experimental group
Treatment:
Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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